Label: SYMPHYTUM OFFICINALE- comfrey plant pellet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated December 27, 2011

If you are a consumer or patient please visit this version.

  • PURPOSE

    BONE TRAUMA, PROMOTES HEALING OF FRACTURES, OR OTHER INDICATIONS

    COMFREY LEAF
  • KEEP OUT OF REACH OF CHILDREN

    WARNING:Keep this and all medications out of reach of children.
  • INDICATIONS & USAGE

    INDICATIONS: To be use according to standard homeopathic indications, for self-limiting conditions such as these indicated above or as directed by a physician.
  • WARNINGS

    WARNING: Use only if cap and seal are unbroken. If symptoms persist for more than 3 days or worsen, discontinue (STOP) use and consult your physician. As with any drug. If you are pregnant or nursing (breast-feeding) a baby, seek the advise of a health professional before using this product. Store tightly closed in a cool area.

  • DOSAGE & ADMINISTRATION

    Directions:(adult/children) Dissolve 3 or 4 pellets in mouth or under tongue 3 times a day or as directed by a physician. Children 2 years and older take 1/2 the adult dose.
  • INACTIVE INGREDIENT

    Inactive Ingredient: Lactose and Sucrose. Free from yeast, wheat, corn and soy.

  • QUESTIONS

    Questions or comments.(877)REM4YOU. Fax (909)594-4205 Pomona, CA. 91768. USA www.remedymakers.com

    Other information: Contain approx.152 - 155 pellets.

  • PRINCIPAL DISPLAY PANEL

    SYMPHYTUMOFFICINALE12C

  • INGREDIENTS AND APPEARANCE
    SYMPHYTUM OFFICINALE 
    comfrey plant pellet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10191-1603
    Route of AdministrationSUBLINGUAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    COMFREY LEAF (UNII: DG4F8T839X) (COMFREY LEAF - UNII:DG4F8T839X) COMFREY LEAF12 [hp_C]
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    LACTOSE (UNII: J2B2A4N98G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10191-1603-2152 in 1 VIAL, GLASS
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic02/04/2004
    Labeler - REMEDY MAKERS (018543582)